Tuberculosis treatment outcomes and patient support groups, southern India

Abstract Objective To assess treatment outcomes in tuberculosis patients participating in support group meetings in five districts of Karnataka and Telangana states in southern India. Methods Tuberculosis patients from five selected districts who began treatment in 2019 were offered regular monthly support group meetings, with a focus on patients in urban slum areas with risk factors for adverse outcomes. We tracked the patients’ participation in these meetings and extracted treatment outcomes from the Nikshay national tuberculosis database for the same patients in 2021. We compared treatment outcomes based on attendance of the support groups meetings. Findings Of 30 706 tuberculosis patients who started treatment in 2019, 3651 (11.9%) attended support groups meetings. Of patients who attended at least one support meeting, 94.1% (3426/3639) had successful treatment outcomes versus 88.2% (23 745/26 922) of patients who did not attend meetings (adjusted odds ratio, aOR: 2.44; 95% confidence interval, CI: 2.10–2.82). The odds of successful treatment outcomes were higher in meeting participants than non-participants for all variables examined including: age ≥ 60 years (aOR: 3.19; 95% CI: 2.26–4.51); female sex (aOR: 3.33; 95% CI: 2.46–4.50); diabetes comorbidity (aOR: 3.03; 95% CI: 1.91–4.81); human immunodeficiency virus infection (aOR: 3.73; 95% CI: 1.76–7.93); tuberculosis retreatment (aOR: 1.69; 1.22–2.33); and drug-resistant tuberculosis (aOR: 1.93; 95% CI: 1.21–3.09). Conclusion Participation in support groups for tuberculosis patients was significantly associated with successful tuberculosis treatment outcomes, especially among high-risk groups. Expanding access to support groups could improve tuberculosis treatment outcomes at the population level.


Introduction
Estimates indicate that India has the largest number of tuberculosis patients (26%) and tuberculosis-related deaths (36%) in the world. 1 India's success in tackling tuberculosis is critical to achieving the global goal of ending tuberculosis by 2030. India's national strategic plan on tuberculosis 2017-2025 envisages achieving a treatment success rate of 92% and 75% among individuals with drug-sensitive and drug-resistant tuberculosis, respectively, by 2025. 2 Overall, the treatment success rate for drug-sensitive and drug-resistant tuberculosis was 81% (1 665 016/2 049 517) and 48% (16 668/34 621), respectively, in 2018. 3 These figures highlight the need for highly effective and rapidly scalable interventions to accelerate the success rate in tuberculosis treatment outcomes.
Treatment approaches that include patients and their family members in a person-centred care process are more likely to be successful. 4,5 Processes for empowering and involving tuberculosis patients in the prevention and control of their disease are of increasing interest to policy-makers, programme managers and health-care providers concerned with tuberculosis control. 6 Many studies on other disease conditions show that empowering and involving patients is feasible using forums that facilitate sharing and learning from other patients' experiences, challenges and successes. [6][7][8][9][10][11][12] Peer support for tuberculosis patients has been attempted in many countries with varying degrees of success. [13][14][15][16] In India, strategies for peer support and patient involvement have rarely been implemented and studied. In this paper, we describe implementation of support group meetings for tuberculosis patients and assess tuberculosis treatment outcomes in patients participating in these meetings.

Study setting
The Tuberculosis Health Action Learning Initiative, funded by the United States Agency for International Development, was implemented in selected districts of two states in southern India during 2016-2020. In total, 46 tuberculosis units from urban areas of Bellary, Bengaluru Urban and Koppal districts in Karnataka state and Warangal and Hyderabad districts in Telangana state were selected for the implementation of support group meetings in 2019. In consultation with state and district tuberculosis programme staff, districts with higher proportions of the urban population living in slums were selected.
Tuberculosis treatment outcomes, India Rajaram Subramanian Potty et al.

Implementation
We locally recruited community health workers (CHWs) from urban communities in 2016. 17 In 2019, senior technical tuberculosis programme staff and technical staff of the project trained the CHWs and tuberculosis programme field staff to jointly organize and conduct monthly support group meetings within the public health facilities offering tuberculosis services. These health workers and programme staff formed support groups for tuberculosis patients who started treatment in 2019. Family members and/or caregivers of the patients and individuals who had previously completed tuberculosis treatment were included in the support groups. Tuberculosis patients who were very ill were excluded from participating. Support group members received information on the date and time of the meetings from CHWs or the tuberculosis programme staff. Initially, the health workers or programme staff provided this information during home or clinic visits. Later, district tuberculosis programme managers designated a specific day and time for the support group meetings and this information was stamped on the patientheld treatment card. The project provided CHWs and programme staff with a list of topics and behaviour change communication materials to facilitate the meetings, and they encouraged participants to actively interact during the meeting. Topics included stigma and disclosure, treatment adherence, nutrition, healthy living and protection of other family members from tuberculosis. Each meeting lasted for 60-90 minutes during which participants discussed only one topic. The groups consisted of 15-20 participants of mixed sex and age. Participants received no remuneration for participation in the meetings. Local donors supported the provision of light refreshments for the participants after the meeting. Tuberculosis programme staff formed additional patient support groups in settings where there were a large number of patients. Attendance of the meetings was voluntary and the CHWs and programme staff did not pressure the tuberculosis patients to attend a specific number of meetings during their treatment. The main intention was that each patient would attend the support group meeting once a month until they completed their treatment course. The CHWs recorded the attendance of the patients in each meeting with the Nikshay unique identification number, and they contacted patients who missed a meeting, either by telephone or personal visit, to maintain the number of participants. Nikshay is the national webbased database for tuberculosis patients developed by the Central Tuberculosis Division. Every tuberculosis patient notified has a unique patient identification number in Nikshay. Details of the support meetings can be found elsewhere. 18,19 Analyses We used quantitative methods to examine the treatment outcomes of patients who attended and did not attend the support group meetings. Our primary record was the meeting register in which the patient's name, age, sex and Nikshay identification number were recorded with the date and place of the meeting. We combined these data with the Nikshay database and removed duplicate entries based on the Nikshay identification number. The Nikshay database contains information on patient characteristics including: district of residence; type of tuberculosis; site of disease; alcohol use; comorbidity with diabetes and human immunodeficiency virus (HIV); and treatment outcomes. We analysed participation in support groups and successful treatment outcomes as the intervention outcomes. In line with national guidelines, we defined successful treatment outcome as cured (negative smear or culture at the end of the completion of treatment) or completed treatment. We report descriptive statistics with frequencies and percentages. We used logistic regression analysis to assess the association between participation in the support group meeting and successful treatment outcomes adjusted for various patient characteristics: age, sex, district of residence, type of tuberculosis case, disease site, comorbidities (diabetes and HIV infection) and regular alcohol consumption. We report unadjusted odds ratios (OR) and adjusted OR (aOR) and 95% confidence intervals (CI) of successful treatment outcomes. We used Stata version 14.0 (StataCorp LLC, College Station, United States of America) for the analysis.

Ethics
The Institutional Ethics Committee of St John's Medical College and Hospital, Bengaluru (study reference no. 187/2019) and the state tuberculosis offices in the two states provided ethics and regulatory approvals for conducting the study. We did not see any difference in participation by sex and age groups 0-14 years and 15-59 years.

Patient characteristics
Of the 3651 patients who attended the meetings, just over half (1958; 53.6%) attended meetings only once and 157 (4.3%) attended five or more meetings ( Fig. 1; (available at: https:// www .who .int/ publications/ journals/ bulletin/ ). Table 2 shows the tuberculosis treatment outcomes according to participation in meetings. Of the 30 706 tuberculosis patients who started treatment, the treatment outcome was missing for 145, of whom 133 did not attend any meetings; these patients were excluded from our analysis. Of patients who attended at least one support meeting, 94.1% (3426/3639) had a successful treatment outcome while 88.2% (23 745/26 922) of patients who did not attend meetings had a successful treatment outcome. Unsuccessful outcomes, including death, loss to follow-up and not evaluated, were slightly higher in patients who did not attend any meetings than in patients who attended at least one meeting.

Treatment outcomes
Overall, a significantly higher proportion of patients who attended support group meetings (94.1%; 3426/3639)  Table 3). The difference in successful treatment outcome by participation in meetings was higher in Bengaluru Urban district than in other districts. Similarly, the higher proportion with a successful treatment outcome in patients who participated in meetings persisted across different characteristics, even for patients with certain risk factors including age ≥ 60 years, drug-resistant tuberculosis, HIV infection, diabetes and regular alcohol consumption (Table 3). Overall, tuberculosis patients who attended support group meetings were two times more likely to have a suc-cessful treatment outcome than non-participating patients (unadjusted OR: 2.15; 95% CI: 1.86-2.48), and higher odds of a successful outcome were seen irrespective of patient characteristics (Table 3).

Research
In the multivariate logistic regression analysis, even after controlling for the potential risk factors, the likelihood of a successful treatment outcome was significantly higher in the patients who attended the support group meetings (Table 4). Overall, after controlling for confounding, the odds of experiencing a successful outcome were 2.4 times greater for the patients who attended the meetings than non-participating patients (aOR: 2.44; 95% CI: 2.10-2.82).
The association between participation in meetings and successful treatment outcome was significant only in the districts of Bengaluru Urban (aOR: 4

Discussion
Participation of tuberculosis patients in support groups while on treatment significantly improved treatment outcomes. This finding persisted even in patients with a higher risk of unsuccessful outcomes, including patients with drug-resistant tuberculosis, HIV infection and diabetes, and regular alcohol consumers. Only one previous qualitative study in Jharkhand, India reported that patient charter meetings empowered tuberculosis patients and enhanced mental and emotional support from their peers and family members. 20 The patient-centred approach, involvement of family members, use of facilities that provided privacy to hold the meetings in, inclusion of tuberculosis programme staff, and the designation of a fixed day and time for the meetings were unique aspects of this implementation research. The meetings created a forum that improved communication and understanding between care providers, patients and their family members. Participation of former tuberculosis patients who had successfully completed treatment in the meetings gave the new patients and their family members confidence about the treatment. Patients and Tuberculosis treatment outcomes, India Rajaram Subramanian Potty et al.
their family members were encouraged to share positive experiences related to treatment. Patients were also encouraged to share their experience of any violation of rights or if they had faced any discrimination or denial of rights within the family, community or facility settings. Occasionally, participants provided information on other individuals with symptoms of tuberculosis living in their own homes or in the community. Thus, this forum also led to the identification of new tuberculosis patients. However, we were not able to estimate the number of tuberculosis patients detected through the attendees of the support group meetings, as this information was not recorded clearly. Box 1 gives a summary of the lessons learnt from implementation of the support groups and their achievements. These lessons can be used for future scaling up and strengthening of the programme.
The support meetings did not include tuberculosis patients who lived in an institutional setting, such as prisons or homeless shelters, or who did not have family support or a caregiver. Our groups were mixed so gender-specific support could not be provided, particularly for women and adolescent girls with tuberculosis whose needs may differ from men and boys. However, the success of peer support appears to be because of the non-hierarchical reciprocal relationship that is created through the sharing of similar life experiences. This approach of community ownership and mobilization is set out in the national strategic plan on tuberculosis and emphasizes the need for involvement of patient networks in planning, implementation and monitoring of the programme through tuberculosis champions. 2,3 Many vocal and confident individuals were identified from these support groups to be trained subsequently as tuberculosis champions. Other studies have shown that peer support approaches are beneficial to patients with other disease conditions. [6][7][8][9][10][11]21,22 Numerous studies have reported that peer support through education, training, self-help groups and clubs improves treatment completion for latent and active tuberculosis. [13][14][15][16]23,24 However, these studies do not report a systematic and standard approach for organizing support group meetings among active tuberculosis patients to improve treatment outcomes. Our study provides information on the process for implementation of support group meetings within a health facility. We did not assess the cost and cost-effectiveness of  the support group meetings because the CHWs perform many different activities 17 and it was not feasible to allocate time spent on this specific activity individually. In addition, we did not estimate the costs of training CHWs and providing materials. However, the cost of conducting a meeting was low as the venue was a public health facility and local donors provided the refreshments. The coronavirus disease 2019 pandemic hindered implementation of the project. With the nationwide lockdown for 21 days on 24 March 2020 and conditional relaxations introduced later, we had to organize virtual support groups using WhatsApp and other virtual platforms. However, this required that at least one member of the household had a smartphone. Fortunately, since the duration of treatment is 6 months, many of the patients who began treatment in 2019 had completed their treatment course before the lockdown.
Our findings have other implications. The outcomes of support group meetings differed between districts. These differences could be because of compromised quality of the support group meetings, the larger size of the groups and the varying levels of successful treatment outcomes within these districts. Nonetheless, even patients with drug-resistant tuberculosis and HIV coinfection who participated in meetings had a greater likelihood of successful treatment outcomes than those who did not participate. Although we did not collect any feedback directly from the participants on the benefits they perceived of attending the meetings, we conducted a process evaluation study using qualitative methods with different stakeholders. 25 A limitation of our study is that only a small proportion of all tuberculosis patients in the districts participated in these meetings, as the meetings were conducted in urban slum settings only. To achieve a greater impact at a population level, access to these meetings needs to be expanded to increase participation

Box 1. Achievements of and lessons learnt from implementation of support group meetings for tuberculosis patients, southern India, 2019 Formation of support groups
It is feasible to form support groups of active tuberculosis patients, former patients who have been cured or have completed treatment, family members or caregivers, and staff of tuberculosis programmes. Fixing a specific day and time for meetings in a health facility is more convenient for participants to attend. Small group size (15-20 participants) increases people's involvement during the meeting, even when the group is heterogeneous.

Capacity-building
Adequate numbers of tuberculosis field staff need to be trained to ensure support group meetings are held regularly. Developing appropriate action points at the end of each meeting in an interactive manner is useful to discuss unanswered issues.

Promotion of the meeting
Tuberculosis programme staff can encourage cured tuberculosis patients to become tuberculosis champions. These former patients attending meetings can convey the benefits of participation to others with tuberculosis symptoms in the family and community, leading to increased detection of tuberculosis cases.

Time efficiency
These meetings are also a forum for programme staff to provide important common information to a group of patients because they may not have time to explain this information to each patient individually.

Community support
The success of meetings largely depends on community support. These meetings can be used as a way to obtain the support of local donors for the provision of food items for the nutritional requirements of patients in need. Indirectly, this support could reduce stigma associated with tuberculosis in the community.

Data
The existing tuberculosis programme data (Nikshay data) can be used to measure the outcomes of meetings. In addition to the existing data, the attendance data of the individual patients and the various activities conducted need to be documented to monitor the programme.

Achievements
Participation in the meetings improved tuberculosis treatment outcomes, irrespective of the risk characteristics of the patient.

Advantages
No additional staff were needed to conduct the meetings. Existing tuberculosis staff can efficiently facilitate the meetings with appropriate training and mentoring. The cost of organizing the meeting can also be reduced by using local venues and resources, such as furniture and refreshments, from the community and the health facility.

Research
Research on support group meetings can be undertaken in different health facilities to determine the best ways to overcome the challenges and to gain community support. Similarly, the perceived benefits felt by patients could be explored using qualitative methods.
Tuberculosis treatment outcomes, India Rajaram Subramanian Potty et al.
rates. The association of participation in meetings with successful treatment outcomes could have been shaped not only by participation in the intervention itself but also by contextual factors outside of the control of participants and tuberculosis programme staff. For example, the provision of tuberculosis treatment services could vary between different health facilities. In our analysis, we used the data of both tuberculosis patients who attended the meetings and those who did not, thus controlling for this bias to some extent. We did not document many of the activities conducted during the meetings so we could not explore the influence of specific activities on the successful outcome. For example, during the meetings, we obtained the support of local donors for the distribution of food items for needy patients but we did not record this support in a separate format. Getting the doctors from the health facilities with the tuberculosis units to engage with and participate in these meetings regularly was a challenge. The participation of these doctors in the support group meetings is important to provide the tuberculosis patients with the information they need, which the junior tuberculosis programme staff are not be able to provide, and increase the patients' confidence in the treatment. Another drawback was the lack of mechanisms to obtain feedback from the various stakeholders to understand the unresolved issues during the meetings for continuous improvement.
Our research provides useful lessons for the implementation of support group meetings at the national level. This approach can be regularized through existing programme staff but would require time and commitment to conduct the meetings regularly. Recently, the Central Tuberculosis Division of the government of India endorsed support group meetings as one of the person-centred care approaches for improved treatment outcomes in its community engagement guidance document. 26

Resumen
Desenlaces del tratamiento de la tuberculosis y grupos de apoyo a los pacientes en el sur de la India Objetivo Evaluar los desenlaces del tratamiento en pacientes con tuberculosis que participan en reuniones de grupos de apoyo en cinco distritos de los estados de Karnataka y Telangana en el sur de la India.
Métodos Se ofrecieron reuniones mensuales regulares de grupos de apoyo a los pacientes con tuberculosis de cinco distritos seleccionados que comenzaron el tratamiento en 2019, con un enfoque en los pacientes de los suburbios urbanos con factores de riesgo de desenlaces Tuberculosis treatment outcomes, India Rajaram Subramanian Potty et al.
Tuberculosis treatment outcomes, India Rajaram Subramanian Potty et al.